The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A in Participants With Neuropathic Non-Healing Diabetic Foot Ulcers

November 20, 2018 updated by: Genentech, Inc.

A Phase Ib, Blinded, Randomized, Multicenter, Multiple-Ascending-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of UTTR1147A Administered by Subcutaneous Injection in Patients With Non-Healing Neuropathic Diabetic Foot Ulcers

This trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeat dosing of UTTR1147A in participants with neuropathic diabetic foot ulcers that do not respond adequately to standard wound care. Participants across multiple sites will be assigned to one of five cohorts (Cohort A, B, C, D, and E) based on the eligibility criteria and randomized to receive subcutaneous (SC) injections of either UTTR1147A or placebo over 12 weeks in addition to standard wound care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Universitetshospital
      • København, Denmark, 2400
        • Bispebjerg Hospital
      • Odense, Denmark, 5000
        • Odense Universitetshospital; Endokrinologisk Afdeling
  • Hungary
      • Balatonfured, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Debrecen, Hungary, 4031
        • Kenezy Korhaz Rendelointezet
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico Di Roma; Farmacia
    • Toscana
      • Firenze, Toscana, Italy, 50141
        • Azienda Ospedaliera Universitaria Careggi
      • Pisa, Toscana, Italy, 56100
        • Azienda Ospedaliero Universitaria Pisana
  • Spain
      • Madrid, Spain, 28040
        • Universidad Complutense de Madrid
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
    • Guipuzcoa
      • Donostia, Guipuzcoa, Spain, 20080
        • Hospital Universitario de Donostia
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
        • Hospital Universitario Cruces
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Derby, United Kingdom, DE22 3DT
        • Royal Derby Hospital; Medical School
      • Ipswich, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • Norfolk, United Kingdom, NR4 7TJ
        • University of East Anglia
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • East Valley Foot and Ankle Specialists
    • California
      • San Francisco, California, United States, 94115
        • Center for Clinical Research Inc.; i
    • Colorado
      • Durango, Colorado, United States, 81301
        • Animas Foot and Ankle
    • Florida
      • Miami Lakes, Florida, United States, 33016
        • GF Professional Research Group Corporation
    • Illinois
      • Belleville, Illinois, United States, 62226
        • Podiatry 1st
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Clinical Research Associates Of Central PA , LLC
    • Texas
      • McAllen, Texas, United States, 78501-2930
        • Futuro Clinical Trials
      • San Antonio, Texas, United States, 78229
        • Endeavor Clinical Trials PA
    • Virginia
      • Suffolk, Virginia, United States, 23434
        • 1Foot 2Foot Centre for Foot & Ankle Care PC
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Steven M. Waldman, SC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a diagnosis of Type 1 or Type 2 diabetes and confirmed peripheral neuropathy
  • Have adequate circulation to the foot
  • Have an ulcer area at screening up to 6 cm^2
  • Up to date on all age-appropriate cancer screenings per local standards

Exclusion Criteria:

  • Have current evidence of osteomyelitis, cellulitis, or evidence of systemic infection
  • Have gangrene present on any part of the affected foot
  • Known peripheral arterial disease requiring revascularization
  • Have a glycated hemoglobin A1C level of greater than (>) 15% assessed at screening
  • Are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents
  • Have active malignancy or any history of a malignancy
  • Use of oral antibiotics at the time of randomization for any reason in participants to be enrolled in Cohorts A, B, E, and any additional uninfected patient cohorts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort A - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 1
Participants with 0.8-6.0 centimeters square (cm^2) index ulcer area at screening and no infection in index ulcer will receive UTTR1147A SC at Dose Level 1 for 12 weeks (a total of 4 doses).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
EXPERIMENTAL: Cohort B - UTTR1147A, 0.8-6.0 cm^2, No Infection - Dose 2
Participants with 0.8-6.0 cm^2 index ulcer area at screening and no infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
EXPERIMENTAL: Cohort C - UTTR1147A, 0.8-6.0 cm^2, Mild Infection - Dose 2
Participants with 0.8-6.0 cm^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
EXPERIMENTAL: Cohort D - UTTR1147A, 1.5-6.0 cm^2, Mild Infection - Dose 2
Participants with 1.5-6.0 cm^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 2 for 12 weeks (a total of 4 doses).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
EXPERIMENTAL: Cohort E - UTTR1147A, 0.8-6.0 cm^2, No infection - Dose 3
Participants with 0.8-6.0 cm^2 index ulcer area at screening and mild infection in index ulcer will receive UTTR1147A SC at Dose Level 3 for 12 weeks (a total of 4 doses).
Drug: UTTR1147A
UTTR1147A will be administered SC.
Other Names:
  • RO7021610
PLACEBO_COMPARATOR: Placebo
Participants will receive UTTR1147A matching placebo SC in each cohort for 12 weeks (a total of 4 doses).
Drug: Placebo
UTTR1147A matching placebo will be administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Adverse Events
Time Frame: Baseline up to Day 141
Baseline up to Day 141

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Index Ulcer Surface Area at Weeks 6 and 12
Time Frame: Baseline, Weeks 6 and 12
Baseline, Weeks 6 and 12
Percentage of Participants with Anti-Therapeutic (Anti-UTTR1147A) Antibodies
Time Frame: Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)
Day 1, 22, 64, 85, 99, early termination visit (up to Day 141)
Serum Concentration of UTTR1147A
Time Frame: Pre-dose (0 h) on Days 1, 22, 43, and 64, on Days 4, 8, 71, 85, and 99, early termination (up to Day 141)
Pre-dose (0 h) on Days 1, 22, 43, and 64, on Days 4, 8, 71, 85, and 99, early termination (up to Day 141)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 14, 2016

Primary Completion (ACTUAL)

November 12, 2018

Study Completion (ACTUAL)

November 12, 2018

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 12, 2016

First Posted (ESTIMATE)

July 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 20, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GX29915
  • 2015-003283-36 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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